NCT06891911

Groceries for Residents of Southeastern USA to Stop Hypertension

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.

Detailed description

Hypertension (HTN) affects half of US adults and is one of the most important modifiable risk factors for cardiovascular disease (CVD) and death. The DASH diet is a proven strategy for lowering blood pressure in adults. Our proposed clinical trial will evaluate the effectiveness of a scalable solution: home-delivered, low-sodium groceries aligned with the DASH dietary pattern and ordered with dietitian assistance via a virtual supermarket, in reducing blood pressure. Participants will be assigned to one of two 1-month long interventions: (1) dietitian-assisted, DASH-patterned, home-delivered groceries ordered weekly through Amazon Fresh (or Whole Foods) over 4 weeks or (2) self-directed grocery shopping (monthly stipend and DASH diet brochure) (referent).

Conditions

• Hypertension
• Elevated Blood Pressure
• Cardiovascular Diseases
• Dietary Intervention

Interventions

Type	Name	Description
BEHAVIORAL	Dietitian-Assisted DASH groceries	The DASH ("Dietary Approaches to Stop Hypertension"), is a healthy dietary pattern that lowers blood pressure without reducing weight. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. Intervention Phase: This intervention is a weekly, 4-week DASH dietary intervention. A dietitian will assist participants in ordering groceries in a pattern consistent with the DASH diet to be delivered to their homes. The quantity of groceries will be based on participant Calorie needs and family size.
BEHAVIORAL	Self-directed shopping	Intervention Phase: Participants will receive some basic information on healthy eating and a stipend during the 4-week intervention period. They are permitted to use the stipend however they choose and will not be asked about how they spent these funds.

Timeline

• Start date: 2025-10-14
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-03-24
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States